AzTrials
AzTrials

Osteoarthritis of KneeNCT07904741

The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis

A study testing Recumbent-Cycle Aerobic Exercise, Lower-Limb Strengthening Exercise and Home Flexibility Exercise Program in people with Osteoarthritis of Knee, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Knee osteoarthritis can cause pain, reduced muscle strength, and difficulty with daily activities. Exercise is commonly used to manage knee osteoarthritis, but the effects of different exercise programs on muscle oxygenation are not fully understood. Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Osteoarthritis of Knee
What is being tested?
Recumbent-Cycle Aerobic Exercise, Lower-Limb Strengthening Exercise and Home Flexibility Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Oct 2026to 20 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 45 to 65 years.
  • Body mass index (BMI) below 30 kg/m².
  • Physician-diagnosed knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.
  • Bilateral knee osteoarthritis of Kellgren-Lawrence grade 2 or 3.
  • Willingness to participate and provide informed consent.

Who cannot join

  • Orthopedic or rheumatologic disease of the lower extremities, or arterial or venous disease.
  • Uncontrolled hypertension, pulmonary disease, or diabetes.
  • Neurological disease.
  • Learning or cognitive impairment that may prevent participation.
  • Knee extension deficit.
  • Physical activity level above 600 MET-minutes/week, assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
  • Treatment for knee osteoarthritis within the previous 6 months, including physical therapy or injection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayşem Ecem Özdemir, Msc PT contact

+905375112777

ecemozdemir6@gmail.com

Yıldız Analay Akbaba, PT, PhD contact

yildizanalay@iuc.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • İstanbul University Cerrahpaşa, Faculty of Health Science, Physiotherapy and Rehabilitation Lab

    Istanbul, 34000

    Ayşem Ecem Özdemir, +9005375112777, ecemozdemir6@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Different Exercise Training Programs on Muscle Oxygenation, Strength, Pain, and Functionality in Individuals With Knee Osteoarthritis

Knee osteoarthritis can cause pain, reduced muscle strength, and difficulty with daily activities. Exercise is commonly used to manage knee osteoarthritis, but the effects of different exercise programs on muscle oxygenation are not fully understood.

This study will compare three 6-week exercise programs in adults with knee osteoarthritis: aerobic exercise on a recumbent bicycle, lower-limb strengthening exercise, and a program combining aerobic and strengthening exercise. Participants will be randomly assigned to one of the three groups. Each group will attend three supervised exercise sessions weekly for 6 weeks. All participants will also receive a home stretching program. Participants will be assessed before the program, at weeks 3 and 6, and again at week 10, after a 4-week period without supervised exercise.

The study will examine whether the exercise programs improve muscle oxygenation and whether changes in muscle oxygenation are associated with changes in muscle strength, pain, and physical function. The investigators expect muscle oxygenation to improve after the exercise programs and expect these changes to be associated with improvements in clinical measures.

Read the detailed description

This is a single-center, parallel-group randomized clinical study planned at the laboratories of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpaşa, Türkiye. The planned enrollment is 60 participants, with 20 participants in each group. Participants will be randomly assigned to an aerobic exercise group, a strengthening exercise group, or a combined aerobic and strengthening exercise group using an online randomization program.

The supervised intervention will last 6 weeks, with three sessions per week, for a total of 18 sessions. Study assessments will take place at baseline and at weeks 3, 6, and 10. No supervised exercise intervention is planned between weeks 6 and 10. All participants will receive the same home flexibility program, consisting of bilateral hamstring and quadriceps stretches and gastrocnemius stretches with a towel or sheet. Participants will be advised to perform the home exercises 3 to 5 days per week.

The aerobic exercise group will train on a recumbent cycle ergometer. Sessions will include a 5-minute warm-up and a 5-minute cool-down. At the beginning of the program, the main exercise period will last approximately 20 to 30 minutes at 40% to 50% of age-predicted maximum heart rate. Exercise duration and intensity will be progressed according to participant tolerance, with a target of approximately 40 to 45 minutes at 60% to 70% of maximum heart rate by week 6. Cadence will be maintained at approximately 60 to 80 revolutions per minute. Heart rate and perceived exertion will be monitored during exercise.

The strengthening exercise group will perform lower-limb exercises, including isometric knee extension, hip flexion, extension, abduction and adduction, clamshell exercise, and knee flexion and extension using ankle weights. Exercises will be performed bilaterally. The program will use 1 to 3 sets of 8 to 12 repetitions, with 90 to 120 seconds of rest between sets. Resistance will begin at approximately 30% of one-repetition maximum and may be progressed toward 60%, depending on participant tolerance. One-repetition maximum will be reassessed every 2 weeks to update exercise loads.

The combined group will perform aerobic and strengthening exercise consecutively during the same session. Exercise progression in all groups will be guided by participant tolerance and pain. Progression will be considered when exercise pain is no greater than 4 on a 0-to-10 scale and there is no persistent increase in pain or symptom exacerbation during the following 24 to 48 hours. Exercise duration or intensity will be reduced if the participant cannot tolerate the prescribed exercise.

The same assessment procedures will be used at each scheduled assessment visit. Muscle oxygenation will be assessed using near-infrared spectroscopy, alongside clinical and physical-function assessments specified in the study record.

Being tested
Recumbent-Cycle Aerobic Exercise, Lower-Limb Strengthening Exercise, Home Flexibility Exercise Program
Keywords
Osteoarthritis of Knee, Muscle oxygenation, Exercise, Pain, Muscle strenght, Function
Medical subject headings
Osteoarthritis, Knee, Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recumbent-Cycle Aerobic ExerciseOther

    Supervised aerobic exercise on a recumbent cycle ergometer, three times per week for 6 weeks (18 sessions). Each session includes a 5-minute warm-up and a 5-minute cool-down. At the beginning of the program, the main cycling will be at 40% to 50% of age-predicted maximum heart rate. Duration and intensity are progressed according to participant tolerance, with a target at 60% to 70% of maximum heart rate by week 6. Cadence is 60 to 80 revolutions per minute. Heart rate and perceived exertion are monitored during exercise.

  • Lower-Limb Strengthening ExerciseOther

    Supervised bilateral lower-limb strengthening exercise, three times per week for 6 weeks (18 sessions). Exercises include isometric knee extension, hip flexion, extension, abduction and adduction, clamshell exercise, and knee flexion and extension using ankle weights. Participants perform 1 to 3 sets of 8 to 12 repetitions, with 90 to 120 seconds of rest between sets. Resistance starts at approximately 30% of one-repetition maximum and may progress toward 60%, according to tolerance and pain response. One-repetition maximum is reassessed every 2 weeks.

  • Home Flexibility Exercise ProgramOther

    Home flexibility exercises provided to participants in all three arms. The program includes bilateral standing hamstring and quadriceps stretches and a towel-assisted gastrocnemius stretch. Each stretch is held at the point of tension for 20 to 30 seconds. Participants are asked to perform the exercises 3 to 5 days per week.

Study groups in NCT07904741
Study groupRoleWhat they receive
Aerobic Exercise TrainingExperimentalParticipants will complete supervised aerobic exercise on a recumbent cycle ergometer three times per week for 6 weeks (18 sessions). Each session will include a warm-up, cycling, and a cool-down. Exercise intensity and duration will be individually adjusted and progressed according to participant tolerance and pain response, with heart rate and perceived exertion monitored during exercise. Participants will also receive the common home stretching program.
Receives: Other: Recumbent-Cycle Aerobic Exercise; Other: Home Flexibility Exercise Program
Strengthening Exercise TrainingExperimentalParticipants will complete supervised bilateral lower-limb strengthening exercises three times per week for 6 weeks (18 sessions). Exercises will include isometric knee extension, hip flexion, extension, abduction and adduction, clamshell exercise, and knee flexion and extension using ankle weights. The program will use 1 to 3 sets of 8 to 12 repetitions, with resistance progressed according to tolerance and pain response. Participants will also receive the common home stretching program.
Receives: Other: Lower-Limb Strengthening Exercise; Other: Home Flexibility Exercise Program
Combined Aerobic and Strengthening TrainingExperimentalParticipants will complete supervised aerobic exercise on a recumbent cycle ergometer and lower-limb strengthening exercises consecutively during each session, three times per week for 6 weeks (18 sessions). Exercise intensity, duration, and resistance will be adjusted according to the participant's tolerance and pain response. Participants will also receive the common home stretching program.
Receives: Other: Recumbent-Cycle Aerobic Exercise; Other: Lower-Limb Strengthening Exercise; Other: Home Flexibility Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle Oxygenation

    1. Resting VMO Muscle Oxygen Saturation (SmO₂): Mean muscle oxygen saturation (SmO₂, %) recorded over 60 seconds after 10 minutes of seated rest, measured over the vastus medialis oblique using near-infrared spectroscopy.
    2. Minimum VMO SmO₂ During Mini-Squat Exercise: Minimum muscle oxygen saturation (SmO₂, %) recorded over the vastus medialis oblique during one set of 20 mini-squats performed at approximately 30 degrees of knee flexion, with a 3- to 4-second hold per repetition and isometric hip adduction.
    3. Post-Exercise VMO SmO₂ Recovery Time: Time in seconds from completion of the mini-squat set until SmO₂ returns to the pre-exercise resting baseline, measured over the vastus medialis oblique.

    Measured: Baseline, week 3, week 6, week 10

Secondary outcomes (7)
  1. Knee Pain

    Participant-rated knee pain at rest using a 0-to-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.

    Measured: Baseline, week 3, week 6, week 10

  2. WOMAC Score

    The Turkish version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will assess pain, stiffness, and physical function. The total score will be normalized to a 0-to-100 scale using (raw total score × 100) / 96; higher scores indicate worse symptoms and function.

    Measured: Baseline, week 3, week 6, week 10

  3. SF-36 Health-Related Quality of Life

    The Turkish version of the 36-Item Short Form Health Survey (SF-36) will be scored across its eight domains on a 0-to-100 scale. Higher scores indicate better health-related quality of life.

    Measured: Baseline, week 3, week 6, week 10

  4. Active Knee Flexion Range of Motion

    Active knee flexion range of motion, measured in degrees with a universal goniometer. Three measurements will be taken and the mean will be used.

    Measured: Baseline, week 3, week 6, week 10

  5. Maximal Isometric Knee Extension Torque

    Maximal isometric knee extension torque, measured in Newton-meters using an isokinetic dynamometer at 15 degrees of knee flexion. Three contractions will be performed and the mean torque will be used.

    Measured: Baseline and weeks 3, 6, and 10.

  6. 30-Second Sit-to-Stand Test

    Number of complete sit-to-stand repetitions performed in 30 seconds from a chair with a seat height of 44 cm, with arms crossed over the chest.

    Measured: Baseline and weeks 3, 6, and 10.

  7. 2-Minute Walk Test

    Distance walked in meters during a 2-minute walk test on a 30-meter corridor.

    Measured: Baseline and weeks 3, 6, and 10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start20 Oct 2026
  3. Primary completion20 Oct 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904741
Sponsor's protocol ID
MONO2
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Recumbent-Cycle Aerobic Exercise, Lower-Limb Strengthening Exercise and Home Flexibility Exercise Program in people with Osteoarthritis of Knee, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayşem Ecem Özdemir, Msc PT (+905375112777, ecemozdemir6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Oxygenation (time frame: Baseline, week 3, week 6, week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in